Condition category
Mental and Behavioural Disorders
Date applied
10/12/2017
Date assigned
19/12/2017
Last edited
17/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Eye Movement Desensitization and Reprocessing (EMDR) is one of the most effective therapy for Posttraumatic Stress Disorder (PTSD). EMDR is a therapy that uses eye movement to help patient’s process distressing memories and beliefs. However, part of the scientific community is skeptical about EMDR, especially whether eye movements or other laterally alternating stimuli play a role in the EMDR effect. It is necessary to provide evidence-based interventions to reduce PTSD-symptoms effectively and efficiently. These treatments are associated with decreases in avoidance, re-experiencing, negative cognitions, and mood-related symptoms. Interventions that not only reduce the PTSD behavioral symptoms but also tackle the underlying psychoneuroendocrine (the relationship of hormones and human behaviour) mechanisms may potentially offer long-term effectiveness. Psychoneuroendocrine mechanism that may play a role in PTSD includes physiological stress reactivity and neuroendocrine stress response. Comprehensive understanding of both behavioral PTSD symptoms and their association with psychophysiological parameters will contribute to the development of indicators of prognosis of treatment outcome and preventive interventions in high-risk groups. The aim of this study is to examine whether regular EMDR treatment is more effective than a similar treatment but without the eye movement components (retrieval only) in terms of reducing PTSD symptoms in PTSD patients. The goal is to investigate whether EMDR results in a more positive change in stress reactivity associated with PTSD symptom reduction as compared to the retrieval only.

Who can participate?
Adults aged 18 and older who attend in the mental health clinic with fulfilling diagnostic criteria for posttraumatic stress disorder (PTSD).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group will receive the EMDR treatment. Those in the second group will receive a similar therapy but excluding the eye movements. After four sessions in each condition, stress reactivity will be measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, the post-intervention assessment will be conducted, including stress-reactivity and PTSD symptoms. Finally, at six months, a follow-up assessment is conducted to be able to evaluate longer-term effectively.

What are the possible benefits and risks of participating?
There is a direct benefit for participation in this study. The participants will gain treatment to reduce their PTSD symptom. This treatment will help their traumatic problem. Their participating will help us in better understanding how effective EMDR may be beneficial for people who suffer from the traumatic event. Recalling traumatic memories may lead to uncomfortable feelings that will most likely quickly pass. However, if participants feel an uncomfortable feeling, there are techniques to reduce and calm their emotion. The therapist will give stabilization technique until they calm.

Where is the study run from?
The study run from Vrije Universiteit Amsterdam (Netherlands) and takes place in Yayasan Pulih, trauma centre in Jakarta, Indonesia.

When is the study starting and how long is it expected to run for?
February 2017 to May 2019

Who is funding the study?
BUDI LN_LPDP (Indonesian Endowment Fund for Education) (Indonesia)

Who is the main contact?
1. Prof.dr.Anja C.Huizink (Scientific)
a.c.huizink@vu.nl
2. Dr. Marit Sijbrandij (Scientific)
e.m.sijbrandij@vu.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Eka Susanty

ORCID ID

Contact details

Vrije Universiteit Amsterdam
Faculty of Behavioural and Movement Sciences
Clinical
Neuro and Developmental Departement
Van der Boechorststraat 1
Amsterdam
1183 DE
Netherlands
+31 20 59 88888
eka.susanty@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ID_01

Study information

Scientific title

A comparison of Eye Movement Desensitization and Reprocessing (EMDR) and Retrieval only Condition for Posttraumatic Stress Symptoms on Physiological Markers: A Randomized Controlled Trial

Acronym

Study hypothesis

1. Psychophysiological parameters of PTSD participants show more positive alterations in the EMDR condition as compared to the retrieval only condition
2. Psychophysiological parameters of PTSD participants show a more positive change in stress reactivity associated with PTSD symptom reduction in the EMDR condition as compared to the retrieval only condition.

Sub-hypothesis :
2.1 Heart Rate level is lower in participants in the EMDR condition
2.2 Cortisol Daily output shows a more normal pattern in the EMDR condition

Ethics approval

Not provided at time of registration

Study design

The study design is Randomized Controlled Trial by using blocked randomization.
Participants will be randomized into two groups (In this study we will compare the EMDR condition with an exposure condition, which consists of a rather similar therapy protocol but excluding the eye movements).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Posttraumatic stress disorder

Intervention

In this study, the design is a randomised controlled trial (RCT) by blocked randomisation. If a participant meets inclusion criteria a baseline assessment, pre-intervention (T0) is conducted before he or she are randomised and introduced to the corresponding study arm (study arm 1 and 2). Participants are randomised to one of two groups. This study compares the EMDR condition with an exposure condition, which consists of a similar therapy protocol but excluding the eye movements.

The time span between T0 and the first intervention session are kept to about one to two weeks. After four sessions in each condition, stress reactivity is measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, post-intervention assessment are conducted (T2), including stress-reactivity, brain activity and PTSD symptoms. Finally, at six months (T3) a follow-up assessment is conducted to be able to evaluate longer-term effectivity. The follow-up assessment are performed in two steps. First, participants are contacted personally and motivated to complete the follow-up instrument. In case participants refuse the telephone interview, they are offered an assessment of the primary outcome only. If participants still refuse, they are asked to provide reasons for their refusal, which is documented.

EMDR therapy is given in six sessions, each session lasts 45-60 minutes. The standard procedure of EMDR are followed: Client history and treatment planning, preparation, assessment, desensitization, installation, body scan, closure, and re-evaluation. In session 1, all procedures steps are conducted and in the others sessions (session 2 to 7), the therapy can be given from the second stage (preparation) and continued to stage 7 (closure) following reevaluation stage, to see the progress of the individual. In the control group, there is no eye movement during exposure of desensitization and installation phases while all the other components of the treatment protocol are kept the same. This tests whether the addition of Eye Movements is necessary to result in better treatment outcomes on both a behavioral level and on a psychoneuroendocrine level.

The endpoints of the study change in neurobiological parameters; Heart rate (HR), Heart Rate Variability (HRV) and Pre-ejection (PEP) responses to trauma-related stimuli. Secondary outcomes of the study are change of cortisol level and reduction in PTSD symptoms based on Clinician-Administered PTSD Scale (CAPS-5), and PCL-5 (PTSD Checklist for DSM-5). CAPS-5 is a structured interview designed to examine the major symptoms of Post-Traumatic Stress Disorder. It consists of item PTSD symptom questions corresponding to DSM-5 diagnosis for PTSD. PCL-5 consists 20 items that assess the 20 DSM 5 symptom of PTSD.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Heart Rate (HR)/Heart Rate Variability (HRV) is measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3)
2. Pre-ejection period (PEP) is measured using the VU AMS device at baseline (T1), during intervention (T1), post-treatment (T2) and 6 months follow up (T3)

Secondary outcome measures

1. Cortisol level is measured using salivary samples using The Salimetrics Cortisol Enzyme Immunoassay Kit at baseline (T0), post-treatment (T2) and six months follow up (T3)
2. PTSD symptom score is measured using CAPS (Clinican Administered PTSD Scale) at baseline (T0), post-treatment (T2) and 6 months follow up (T3)
3. PTSD symptom score is measured using PTSD Checklist for DSM-5 at baseline (T0), post-treatment (T2) and six months follow up (T3)

Overall trial start date

02/02/2017

Overall trial end date

30/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Individuals who were either diagnosed posttraumatic stress disorder (PTSD) by a professional, i.e., by a clinical psychologist and meet DSM-V-TR, the diagnostic rule which requires at least one criteria of A, B, and C and at least two criteria of D and E and with cut off 33 of PCL-5 score
2. Suffering from posttraumatic stress symptoms on a subclinical level with one symptom in each criterion of PTSD symptoms and with cut off 20 of PCL-5 score
3. Minimal age of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We expect to detect a difference between the EMDR condition and the exposure condition of a medium effect size (cohen’s d = 0.04). Based on this assumption, we need a total sample size of n=70

Participant exclusion criteria

1. Individuals with current organic disorders, psychotic disorders, substance abuse, or suicidal ideation will be excluded
2. Individuals that are currently taking any medication for psychological or psychiatric disorders are excluded

Recruitment start date

01/08/2018

Recruitment end date

31/08/2018

Locations

Countries of recruitment

Indonesia

Trial participating centre

Yayasan Pulih (The Lead Centre)
Jl Teluk Peleng No,63 RT 5/ RW8 Pasar Minggu Jakarta Selatan
Jakarta
12520
Indonesia

Trial participating centre

Klinik Utama Azzalea (Yayasan Jari)
Jalan Sukajadi No.149 Bandung
Jawa Barat
40166
Indonesia

Trial participating centre

Trauma centre of Refugee Survivors of the Agung’s volcano disaster
Bali
-
Indonesia

Sponsor information

Organisation

BUDI LN_LPDP (Indonesian Scholarship)

Sponsor details

A.A Maramis II Building 2nd floor
Jl Lapangan Banteng Timur no 1
Jakarta
10710
Indonesia

Sponsor type

Government

Website

www.lpdp.kemenkeu.go.id

Funders

Funder type

Not defined

Funder name

Indonesia Endowment Fund for Education (LPDP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Eka Susanty (e.s.susanty@vu.nl).

Intention to publish date

01/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/07/2018: The following changes have been made to the trial record: 1. The recruitment start date has been changed from 01/04/2018 to 01/08/2018 2. The recruitment end date has been changed from 30/06/2018 to 31/08/2018 3. The overall trial end date has been changed from 30/05/2019 to 30/07/2019 4. The intention to publish date has been changed from 01/12/2019 to 01/07/2020